A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active Crohn's disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology.
  • - Must have moderately to severely active Crohn's disease (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [>] 30); have ileocolonoscopy with evidence of active Crohn's disease defined as presence of ulceration (which is equal to Simple Endoscopic Score for Crohn's disease [SES-CD] score greater than or equals to [>=] 3) during screening into this study.
If unable to evaluate ulceration due to stricture or inadequate bowel preparation, at least one of the following criteria may instead be applied: an abnormal C-reactive protein (CRP) (> 0.3 milligram per deciliter [mg/dL] or 3.0 milligram per liter [mg/L] at screening) or; fecal calprotectin of >= 250 milligram per kilogram [mg/kg] or >= 250 microgram per gram [mcg/g] at screening.
  • - If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to induction week 0 (Week I-0) - Females of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening, and then have a negative urine pregnancy test at Week I-0 prior to study intervention administration.

Exclusion Criteria:

  • - Has complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of treatment with ustekinumab.
  • - Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening.
  • - Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly.
  • - Have a history of moderate or severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic disturbances.
- Received an investigational intervention including any investigational vaccines or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or is currently enrolled in an investigational study; receipt of an investigational vaccine for Coronavirus Disease 2019 (COVID-19) is not an automatic exclusion criterion

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04673357
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Germany, Hungary, Japan, Poland, Russian Federation, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Open- Label Ustekinumab Intravenous (IV): Induction Period

All Participants will receive a single, open-label IV ustekinumab induction dose at induction week 0 (Week I-0). For participants with body weight less than (<) 40 kilograms (kg) dosing will be body surface area (BSA)-adjusted: ustekinumab 250 milligram per meter square (mg/m^2). For participants with body weight greater than or equal to (>=) 40 kg dosing will be based on a weight-tiered as follows: at 260 milligram (mg) dose for >= 40 kg to less than or equal to (<=) 55 kg body weight; at 390 mg dose for greater than (>) 55 kg to <= 85 kg body weight; and at 520 mg dose for > 85 kg body weight.

Experimental: Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period

Participants with >= 40 kg body weight will receive 90 mg and with < 40 kg body weight will receive 60 mg/m^2 SC ustekinumab at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 once every 8 week.

Experimental: Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period

Participants with >= 40 kg body weight will receive 90 mg and with < 40 kg body weight will receive 60 mg/m^2 SC ustekinumab at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 once every 8 week.

Interventions

Drug: - Ustekinumab

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Drug: - Placebo

Matching placebo will be administered as SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nemours DuPont Hospital for Children, Wilmington, Delaware

Status

Not yet recruiting

Address

Nemours DuPont Hospital for Children

Wilmington, Delaware, 19803

Atlanta, Georgia

Status

Recruiting

Address

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342

Mayo Clinic, Rochester, Minnesota

Status

Not yet recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Morristown Memorial Hospital, Morristown, New Jersey

Status

Not yet recruiting

Address

Morristown Memorial Hospital

Morristown, New Jersey, 07962

Cohen Children's Medical Center, Lake Success, New York

Status

Withdrawn

Address

Cohen Children's Medical Center

Lake Success, New York, 11042

Levine Children's at Atrium Health, Charlotte, North Carolina

Status

Not yet recruiting

Address

Levine Children's at Atrium Health

Charlotte, North Carolina, 28207

Cleveland, Ohio

Status

Not yet recruiting

Address

University Hospitals Case Medical Center Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Cleveland Clinic, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Penn State Hershey Children's Hospital, Hershey, Pennsylvania

Status

Not yet recruiting

Address

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033

Greenville, South Carolina

Status

Withdrawn

Address

Center For Digestive Health Systems-Greenville

Greenville, South Carolina, 29615

Children's Medical Center of Dallas, Dallas, Texas

Status

Not yet recruiting

Address

Children's Medical Center of Dallas

Dallas, Texas, 75390-9063

Pediatric Specialists Of Virginia, Fairfax, Virginia

Status

Recruiting

Address

Pediatric Specialists Of Virginia

Fairfax, Virginia, 22031

Seattle Children's Hospital, Seattle, Washington

Status

Withdrawn

Address

Seattle Children's Hospital

Seattle, Washington, 98105

International Sites

Brussel, Belgium

Status

Not yet recruiting

Address

Universitair Kinderziekenhuis Koningin Fabiola

Brussel, , 1020

Cliniques Universitaires Saint-Luc, Brussel, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussel, , 1200

UZ Gent, Gent, Belgium

Status

Not yet recruiting

Address

UZ Gent

Gent, , 9000

UZ Brussel, Jette, Belgium

Status

Recruiting

Address

UZ Brussel

Jette, , 1090

UZ Leuven, Leuven, Belgium

Status

Not yet recruiting

Address

UZ Leuven

Leuven, , 3000

Universitätsklinikum Aachen, Aachen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Aachen

Aachen, , 52074

Berlin, Germany

Status

Not yet recruiting

Address

Charite-Universitätsmedizin Berlin - Berlin

Berlin, , 13353

Universitatsklinikum Essen, Essen, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Essen

Essen, , 45147

Medizinische Hochschule Hannover, Hannover, Germany

Status

Not yet recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Dr. von Haunersches Kinderspital, Munich, Germany

Status

Not yet recruiting

Address

Dr. von Haunersches Kinderspital

Munich, , 80337

KUNO Klinik St. Hedwig, Regensburg, Germany

Status

Not yet recruiting

Address

KUNO Klinik St. Hedwig

Regensburg, , 93049

Universitätsklinikum Ulm, Ulm, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Ulm

Ulm, , 89075

Semmelweis Egyetem, Budapest, Hungary

Status

Not yet recruiting

Address

Semmelweis Egyetem

Budapest, , 1083

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Status

Not yet recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, , 4032

Miskolc, Hungary

Status

Not yet recruiting

Address

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, , 3526

Nyiregyhaza, Hungary

Status

Not yet recruiting

Address

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz

Nyiregyhaza, , 4400

Szeged, Hungary

Status

Not yet recruiting

Address

Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

Szeged, , 6720

Juntendo University Hospital, Bunkyo-Ku, Japan

Status

Not yet recruiting

Address

Juntendo University Hospital

Bunkyo-Ku, , 113-8431

Gunma University Hospital, Gunma, Japan

Status

Not yet recruiting

Address

Gunma University Hospital

Gunma, , 371-0034

Kindai University Nara Hospital, Ikoma, Japan

Status

Not yet recruiting

Address

Kindai University Nara Hospital

Ikoma, , 630-0293

Kurume University Hospital, Kurume, Japan

Status

Not yet recruiting

Address

Kurume University Hospital

Kurume, , 830-0011

Saitama Children's Medical Center, Saitama-shi, Japan

Status

Not yet recruiting

Address

Saitama Children's Medical Center

Saitama-shi, , 330-8777

Miyagi Children'S Hospital, Sendai-shi, Japan

Status

Not yet recruiting

Address

Miyagi Children'S Hospital

Sendai-shi, , 989-3126

Setagaya-ku, Japan

Status

Not yet recruiting

Address

National Center for Child Health and Development

Setagaya-ku, , 157-8535

Jichi Medical University Hospital, Shimotsuke, Japan

Status

Not yet recruiting

Address

Jichi Medical University Hospital

Shimotsuke, , 329-0498

Mie University Hospital, Tsu, Japan

Status

Not yet recruiting

Address

Mie University Hospital

Tsu, , 514-8507

Szpital im. M. Kopernika, Gdansk, Poland

Status

Not yet recruiting

Address

Szpital im. M. Kopernika

Gdansk, , 80-803

Krakow, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , 30-663

Gabinet Lekarski Bartosz Korczowski, Rzeszow, Poland

Status

Recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszow, , 35-302

Szpital Pomnik Centrum Zdrowia Dziecka, Warszawa, Poland

Status

Not yet recruiting

Address

Szpital Pomnik Centrum Zdrowia Dziecka

Warszawa, , 04-730

Wroclaw, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , 50-369

Kazan State Medical University, Kazan, Russian Federation

Status

Not yet recruiting

Address

Kazan State Medical University

Kazan, , 420138

Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation

Status

Not yet recruiting

Address

Kemerovo Regional Clinical Hospital

Kemerovo, , 650066

Moscow, Russian Federation

Status

Not yet recruiting

Address

Russian National Research Medical University named after N.I.Pirogov

Moscow, , 119571

Moscow, Russian Federation

Status

Not yet recruiting

Address

FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

Moscow, , 119991

Nizhny Novgorod, Russian Federation

Status

Not yet recruiting

Address

Privolzhsky Research Medical University of Ministry of Health of Russian Federation

Nizhny Novgorod, , 603950

Saratov State Medical University, Saratov, Russian Federation

Status

Not yet recruiting

Address

Saratov State Medical University

Saratov, , 410054

Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

Yaroslavl Regional Children's Clinical Hospital

Yaroslavl, , 150032

Birmingham Children's Hospital, Birmingham, United Kingdom

Status

Not yet recruiting

Address

Birmingham Children's Hospital

Birmingham, , B4 6NH

Cambridge, United Kingdom

Status

Not yet recruiting

Address

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , CB2 0QQ

Edinburgh, United Kingdom

Status

Not yet recruiting

Address

Royal Hospital for Children and Young People

Edinburgh, , EH16 4TJ

Royal London Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Royal London Hospital

London, , E1 2AT

King's College Hospital, London, United Kingdom

Status

Not yet recruiting

Address

King's College Hospital

London, , SE5 9RS

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